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510(k) Data Aggregation
K Number
K222394Device Name
Electronic Sphygmomanometers
Manufacturer
Date Cleared
2023-03-03
(207 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Yasee Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Electronic Sphygmomanometer (Model JN-163EW) is a home use digital monitor intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.5 cm to 19.5 cm.
The device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Device Description
Electronic Sphygmomanometer is designed to measure the systolic and diastolic blood pressure of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This is a home use device.
Measurement method to define systolic and diastolic pressure is similar to the Oscillometric method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. With a sensor, the microprocessor converts tiny alterations in cuff pressure to electrical signals and analyzes those signals to define the systolic and diastolic blood pressure and calculates heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".
The electronic sphygmomanometer achieves its function by a software. As the hardware includes an LCD, it can show the results of the blood pressure measurements and store 99 groups of data which can be checked and deleted.
The device is composed of a main unit and a cuff unit. The cuff unit, which is applicable to wrist circumference approximately between 13.5 and 19.5 cm, includes the inflatable bladder and shell. The main unit consists of the microprocessor, pressure sensor, pump, the electromagnetic deflation control valve and the battery. The subject device is powered by 2X AAA Lithium battery.
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K Number
K220084Device Name
Infrared Forehead Thermometer
Manufacturer
Date Cleared
2022-09-12
(245 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Yasee Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Infrared Forehead Thermometers (model2: JA-11S; model3: JA-11C) are non-sterile, reusable, noncontact and handheld devices. They can be used by consumers in homecare environment and doctors in clinic as reference. They are intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
Device Description
Infrared Forehead Thermometers (model1: JA-11A; model2: JA-11S; model3: JA-11C) are hand-held, battery powered, Infrared Forehead Thermometers that covert a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an equivalent temperature when measuring from 1-3 cm of the subject's forehead with no contact.
It is composed of a probe, a display, two buttons (start button and power button), an enclosure and a battery cover.
It is used to measure human body temperature based on the relationship between temperature and measurable infrared radiation. Simply aim the unit's probe toward the surface to be measured to obtain a quick and accurate temperature.
When measuring body temperature, users need to measure in body mode from 1-3 cm from their forehead. Press the measuring key and then release it. The instrument will start measuring the target temperature. After about 1 second, the buzzer emits the corresponding alert sound, the measurement result is displayed on the LCD, and the backlight of the corresponding color is turned on. After about 3 seconds, the backlight is turned off, the unit symbol flashes, and the buzzer beeps shortly. Wait until the key is pressed to measure the temperature again. Start the thermometer without any operation, or no operation after temperature measurement, the thermometer will shut off and LCD go out with one short beep in 60 s ± 20 s.
It can store 32 sets of measurements. Press the 【M】button to cycle through them.
User contact components are the enclosure and keys. The materials of the components are ABS plastic.
The thermometer is for intermittent use.
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